Catalog Number 8065977763 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Product evaluation: complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause: root cause has not been identified (b)(4).
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Event Description
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A doctor reported an intraocular lens (iol) cartridge broke during a cataract with iol implant procedure.The crack occurred at the nozzle top of the cartridge when implanting the iol.There was no patient impact reported.
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Manufacturer Narrative
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The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified lens/cartridge combination was indicated.A non-qualified handpiece was indicated.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause is most likely related a failure to follow the dfu.The account used a cartridge/handpiece combination which was not qualified for use.The use of non-qualified combinations may result in delivery issues and/or damage.Procedures and processes exist within the manufacturing environment that focus on protection of the cartridge tip.There are two other complaints in this lot.Investigation has been completed based on current information.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information provided in d.9, h.2, h.3, h.6.And h.10.Product evaluation: the cartridge was returned in a small plastic bag.Viscoelastic was observed dried throughout the cartridge.Stress line was observed in the thick nozzle cone wall along the anterior and posterior.The stress extended into the tip.The cartridge tip has heavy stress lines and a posterior aneurysm that has torn at the tip exit.This damage was most likely interpreted as the reported complaint of "broken".The cartridge has evidence of being placed into a handpiece.A photo in the file matched the condition of the returned sample.All product and batch history records are quality reviewed prior to product release.A qualified lens and unknown handpiece were used with the cartridge.A non-qualified viscoelastic was indicated.Root cause: the cartridge had heavy stress beginning in the nozzle that extended into the tip.The tip had an aneurysm that has split at the tip exit on the posterior.This was most likely interpreted as the reported complaint.The root cause may be related to a failure to follow the dfu.The viscoelastic indicated was not qualified for the lens/monarch combination used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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